MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number	1013470-100
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.There was no damage noted to the balloon catheter prior to use or leak noted during preparation, which suggests a product quality issue did not contribute to the reported difficulties.In this case, based on the reported information, it is likely the balloon interacted with the moderately torturous, heavily calcified vessel/lesion during advancement causing resistance such that the balloon became damaged and subsequently ruptured.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that this was a procedure to treat a lesion with heavy calcification and no tortuosity in the right mid/distal superficial femoral artery (sfa).The 6.0 mm x 100 mm x 150 cm armada 18 balloon catheter was advanced to the target lesion without issue for pre-dilatation.The balloon was inflated twice successfully at 4 and 6 atmosphere (atm) and was removed intact.The armada 18 balloon catheter was advanced a second time, but the balloon ruptured at 10 atm during the 3rd inflation.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: ARMADA 18 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9954691
• Report Number: 2024168-2020-03603
• Device Sequence Number: 16307236
• Product Code: LIT
• UDI-Device Identifier: 08717648208423
• UDI-Public: 08717648208423
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K151317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 1013470-100
• Device Catalogue Number: 1013470-100
• Device Lot Number: 9102241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 04/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 88